Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin
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|ClinicalTrials.gov Identifier: NCT04231435|
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin, rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows:
- Screening phase
- Treatment phase (includes baseline)
- Follow-up telephone call Subjects will be screened for eligibility during the screening phase. Subjects who meet all inclusion criteria and none of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified assessments, and will be domiciled at the clinical site from Day -1 through the morning of Day 22.
During the study, blood samples will be collected at prespecified times for PK and PD. Urine samples will be collected at prespecified times for urinary PK evaluation of metformin. Subject safety will be monitored throughout the study.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Fedratinib Drug: Digoxin Drug: Rosuvastatin Drug: Metformin||Phase 1|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label Study to Evaluate the Influence of Fedratinib on the Pharmacokinetics of Transporter Probe Substrates (Digoxin, Rosuvastatin, and Metformin) in Healthy Adult Subjects|
|Actual Study Start Date :||December 18, 2019|
|Estimated Primary Completion Date :||February 5, 2020|
|Estimated Study Completion Date :||February 10, 2020|
Experimental: Treatment Administration
All subjects will receive the following oral doses of IP following an overnight fast in the fixed-sequence below:
- Pharmacokinetic - Cmax (Digoxin, Rosuvastatin and Metformin [ Time Frame: 96 hours ]Maximum observed plasma concentration
- Pharmacokinetic - AUC (Digoxin, Rosuvastatin and Metformin [ Time Frame: 96 hours ]Area under the curve
- Pharmacokinetic - CLr [ Time Frame: 48 hours ]Renal Clearance
- Analysis of Glucose AUC after OGTT using linear trapezoidal method [ Time Frame: 3 hours ]Area under the curve
- Adverse Events (AEs) [ Time Frame: From the time the ICF is signed until study completion and up to 30 days after the last dose of IP ]An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231435
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|United States, Texas|
|PPD Phase 1 Clinic||Recruiting|
|Austin, Texas, United States, 78744|
|Study Director:||Leon Carayannopolous, M.D.||Celgene|